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Compliance In Focus


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Posted by John Lehmann on Wed, Mar 04, 2015

FDA’s To-Do List 2013 - PART I

The CDRH (Center for Devices and Radiological Health) recently released their annual proposed Guidance development document for the upcoming fiscal year. This provides an overview of the intended guidance documents FDA plans to fully publish, and those documents FDA hopes to publish.

Topics: To-Do List, Center for Devices and Radiological Health, Medical Device User Fee Act, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

Clinical Research: The To-Do List Goes On and On….

Everyone has a “To-Do” List or lists; Things to do at work, at home, during the week, on the weekends, sometimes even on vacations.  To-do lists pile up and add up.  Just when you think that your list may be shortening, more to-do’s get added on or new lists are started.

Topics: Coordinators, To-Do List, Clinical Research

Clinical Research Training Requirements
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clinical research Training requirements

This whitepaper examines the similarities and differences between various US and international regulations and place them within the context of any number of roles found within the realm of clinical research.